NCT00821665

Brief Summary

Hyperglycemia forms a direct and independent risk factor for the development of cardiovascular co-morbidities in type 2 diabetes. Consumption of sucrose-sweetened soft drinks might further increase the prevalence of hyperglycemic episodes. The objective of the study was to assess glycemic control in type 2 diabetes patients and healthy lean and obese controls under strict dietary standardization but otherwise free living conditions, with and without the consumption of soft drinks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
Last Updated

January 13, 2009

Status Verified

January 1, 2009

Enrollment Period

1.5 years

First QC Date

January 12, 2009

Last Update Submit

January 12, 2009

Conditions

Type 2 DiabetesGlycemic Control

Keywords

Type 2 diabetesGlycemic control(postprandial) HyperglycemiaSucrose

Outcome Measures

Primary Outcomes (1)

  • Hyperglycemia

    24h

Secondary Outcomes (1)

  • Hyperglycemia

    Postprandially

Study Arms (2)

Sucrose

EXPERIMENTAL

Sucrose

Dietary Supplement: Sucrose consumption

Water

PLACEBO COMPARATOR

Water

Dietary Supplement: water consumption

Interventions

Sucrose consumptionDIETARY_SUPPLEMENT

Sucrose

Sucrose
water consumptionDIETARY_SUPPLEMENT

water

Water

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Lean NGT Group
  • Normoglycemic (according to 2006 ADA guidelines)
  • BMI \< 27 kg/m2
  • Obese NGT Group
  • Normoglycemic
  • BMI 30- 35 kg/m2
  • Obese type 2 diabetes Group
  • BMI 30- 35 kg/m2
  • Oral blood glucose lowering medication

You may not qualify if:

  • Exogenous insulin use
  • Cardiac disease (any cardiac event in the last 5 years)
  • HbA1c \>10%
  • Microalbuminuria: albumin:creatinine ratio \>2,5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limbrug, 6200 MD, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hyperglycemia

Interventions

Drinking

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

EatingNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Luc J van Loon, Ph.D

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2009

First Posted

January 13, 2009

Study Start

March 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

January 13, 2009

Record last verified: 2009-01

Locations

NL(1)